Regulatory Affairs Manager - Medical Writer

Team

We are an Industrial Pharmacist and a Medical Doctor. Together we have over 30 years of experience in the pharmaceutical industry.

Experience

We worked for various pharmaceutical companies, small pharma, big pharma and CRO's.

Experience

  • Knowledge of regulatory legislation and guidelines for medicinal products and medical devices
  • Providing drug and device regulatory input to ensuring implementation of a successful regulatory strategy
  • Submission and maintenance of regulatory documents for all phases of the product life-cycle, including eCTD, PSUR's and CTA submissions
  • Review and approval of medical information and publicity
  • Drug safety and pharmacovigilance
  • Working with regulatory bodies

Pricing & Reimbursement

  • Knowledge current legislation and guidelines with regard to pricing and reimbursement of medicinal products in Belgium and Luxemburg
  • Submission and follow-up of applications for price and reimbursement of medicines in Belgium and Luxemburg

Medical Writing

Writing of Monographs, SmPC's, PIL's, PSUR's, Review Articles, Posters, Marketing Material and Presenations

Availability

Available for short to long term projects, including responsibility as qualified person, qualified person for pharmacovigilance or pharmacist responsible for information and publicity